29 days old

Advanced Product Assurance Engineer (Flemington, NJ)

Flemington, NJ 08822
  • Job Code

3M is seeking an Advanced Product Assurance Engineer for the Infection Prevention Division (IPD) located in Flemington, NJ.  At 3M, you can apply your talent in bold ways that matter.  Here, you go.

Job Summary:

The person hired for this position will own multiple commercialized product lines, with a focus on chemical indicators, and manage change control and quality improvements in our Device Reprocessing business.  This individual will lead and support projects that appreciably impact quality, performance, service, and cost, and will collaborate cross-functionally to include manufacturing, regulatory, lab, business, and plant personnel.

 Primary Responsibilities include but are not limited to the following:

  • Driving existing product quality improvement through use of continuous improvement methods and tools, such as:  Six Sigma, PPU (Product and Process Understanding), Design of Experiments, CQI (Customer Quality Index) and Quality at the Source. 
  • Supporting and interacting with customers through complaint investigations, resolution, and trending. 
  • Ensuring the commercialized product design intent and product integrity is retained as materials, processes, methods, and specifications change.
  • Leading and overseeing change management as it relates to design changes driven by quality improvement, source of supply changes, or cost reduction efforts.
  • Leading trouble shooting, investigation, and analysis for non-conforming product testing and disposition.
  • Collaborating with regulatory, manufacturing, laboratory, clinical, tech service, plant personnel.
  • Leading cross functional teams that include manufacturing, technical service and quality/regulatory engineers.
  • Supporting and/or leading efforts on life cycle management, risk management, product and process improvements, and other product documentation efforts.
  • Acting as the primary product liaison between the plant and other divisional functions.
  • Other duties as assigned.

Basic Qualifications: 

  • Bachelor's degree or higher in a science or engineering discipline from an accredited institution
  • Minimum of one (1) year combined product, quality and/or manufacturing engineering experience

Preferred Qualifications:

  • Bachelor’s degree or higher in Chemistry, Chemical Engineering, or Material Science from an accredited institution
  • Minimum of three (3) year of experience in a manufacturing plant and/or reactive chemistries
  • Experience running small scale investigative experimentation in a laboratory or pilot plant
  • Possess a sound quality and regulatory mindset
  • Project leadership experience
  • Minimum of one (1) year of Lean manufacturing experience with a working knowledge of product and process understanding (PPU) and Lean principles
  • Strong emphasis on applied statistical applications and continuous improvement methodologies
  • Experience in product quality assurance for regulated products
  • Experience working with quality systems applied to the health care industry (Medical Device ISO 13485, FDA QSR and Drug GMP)
  • Demonstrated experience to analyze problems, diagnose root cause and apply corrective actions
  • Strong analytical problem solving skills
  • Strong collaboration skills
  • Excellent verbal and written communication skills
  • Self-driven with excellent organization and leadership skills

Location:  Flemington, NJ

Travel:  May include up to 10% domestic

Relocation:  Is authorized                          

Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status)

See job description.

Sponsored by:
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Sponsored by:
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Advanced Product Assurance Engineer (Flemington, NJ)

Flemington, NJ 08822

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Flemington, NJ

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